10.8 mg戈舍雷林与3.6 mg戈舍雷林在绝经前和围绝经期中国激素受体阳性乳腺癌患者中的实际疗效：一项队列研究

IF 9.4 Q1 ONCOLOGY

Journal of the National Cancer Center Pub Date : 2025-05-20 DOI:10.1016/j.jncc.2025.02.006

Yongsheng Wang , Xi Wang , Jiong Wu , Hong Liu , Jiuda Zhao , Jian Huang , Jianxia Liu , Youling Gong , Hao Wang , Huaqing Yang , Guorong Zou , Quchang Ouyang , Guoqin Jiang , Huijuan Liu , Sujie Ni , Binghe Xu , Jinming Yu

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引用次数: 0

摘要

背景：很少有研究比较3个月10.8 mg戈舍林和3.6 mg库舍林对绝经前激素受体阳性（HR+）乳腺癌患者诱导卵巢功能抑制的效果。我们在中国进行了一项大规模的真实世界研究（RWS），以验证10.8 mg戈舍林与3.6 mg库戈舍林的非劣效性。方法这项多中心、回顾性、前瞻性、非效性研究比较了10.8 mg和3.6 mg戈舍雷林对绝经前和围绝经期HR+乳腺癌患者雌二醇（E2）水平的抑制作用。确定了符合条件的患者，并从医院病历中获得了他们的人口统计学和临床数据。观察期28周。倾向评分匹配（PSM）确保了基线的可比性。主要终点是第12±4周E2抑制患者与绝经后水平的比例。采用纽科姆-威尔逊评分法计算比例差异和95% CI。非劣效性边际为- 10%。亚组分析和敏感性分析评估结果的稳健性。结果2015年1月1日至2023年12月15日，共筛选全国16家医院15629例患者，纳入全分析集患者1060例(3.6 mg组678例；10.8 mg组：382)。psm后，对590例患者（每组295例）进行主要终点分析。在第12±4周，10.8 mg组E2抑制患者比例为99.1% (95% CI: 96.9% - 99.8%)， 3.6 mg组E2抑制患者比例为95.3% （95% CI: 91.0% - 97.6%）。差异为3.8% (95% CI: 0.6% - 8.1%)， 95% CI的下限大于非劣效性边际。所有亚组分析，包括基于年龄（≤45岁或>；45岁）和既往化疗（是/否）的亚组分析，以及主要终点的所有敏感性分析均与主分析一致。结论该RWS验证了戈舍林在中国HR+乳腺癌患者中，10.8 mg - 3个月至3.6 mg - 3个月的非效性，在这两个剂量组中，E2抑制率都很高。临床试验注册（NCT05184257）。

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Real-world effectiveness of goserelin 10.8-mg compared to goserelin 3.6-mg in premenopausal and perimenopausal Chinese patients with hormone receptor positive breast cancer: a cohort study

Background

Few studies compared the effectiveness of the 3-monthly goserelin 10.8-mg and the monthly 3.6-mg depot in inducing ovarian function suppression for premenopausal patients with hormone receptor positive (HR+) breast cancer. We conducted a large-scale real-world study (RWS) in China to validate the non-inferiority of goserelin 10.8-mg to the 3.6-mg depot.

Methods

This multicenter, retrospective-prospective, non-inferiority study compared goserelin 10.8-mg with 3.6-mg in suppressing estradiol (E2) levels in premenopausal and perimenopausal patients with HR+ breast cancer. Eligible patients were identified, and their demographic and clinical data were obtained from hospital medical records. The observation period was 28 weeks. Propensity score matching (PSM) ensured baseline comparability. The primary endpoint was the proportion of patients with E2 suppression to postmenopausal level at Week 12±4. Difference in proportions and 95 % CI was calculated by Newcombe-Wilson score method. The non-inferiority margin was -10 %. Subgroup and sensitivity analyses assessed result robustness.

Results

From 1st January, 2015 to 15th December, 2023, 15,629 patients from 16 hospitals nationwide were screened, with 1,060 eligible patients included in the full analysis set (3.6-mg group: 678; 10.8-mg group: 382). Post-PSM, the primary endpoint was analyzed in 590 patients (295 in each group). At Week 12±4, the proportion of patients with E2 suppression was 99.1 % (95 % CI: 96.9 %–99.8 %) for goserelin 10.8-mg and 95.3 % (95 % CI: 91.0 %–97.6 %) for goserelin 3.6-mg. The difference was 3.8 % (95 % CI: 0.6 %–8.1 %) with the lower limit of 95 % CI greater than the non-inferiority margin. All subgroup analyses, including those based on age (≤45 or >45 years) and previous chemotherapy (yes/no), and all sensitivity analyses on the primary endpoint were consistent with the main analysis.

Conclusions

This RWS validated the non-inferiority of goserelin 10.8-mg 3-monthly to 3.6-mg monthly in Chinese patients with HR+ breast cancer, where high E2 suppression rates were achieved in both goserelin dosage groups.